Trial Outcomes & Findings for Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study) (NCT NCT01397448)
NCT ID: NCT01397448
Last Updated: 2014-11-26
Results Overview
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
472 participants
Primary outcome timeframe
24 weeks
Results posted on
2014-11-26
Participant Flow
Participant milestones
| Measure |
Rabeprazole 5 mg
Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Rabeprazole 10 mg
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Teprenone 150 mg
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
|
|---|---|---|---|
|
Overall Study
STARTED
|
156
|
157
|
158
|
|
Overall Study
COMPLETED
|
138
|
142
|
140
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
18
|
Reasons for withdrawal
| Measure |
Rabeprazole 5 mg
Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Rabeprazole 10 mg
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Teprenone 150 mg
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
5
|
|
Overall Study
Other
|
8
|
7
|
4
|
Baseline Characteristics
Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Baseline characteristics by cohort
| Measure |
Rabeprazole 5 mg
n=156 Participants
Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Rabeprazole 10 mg
n=157 Participants
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Teprenone 150 mg
n=158 Participants
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
|
Total
n=471 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.3 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
70.1 Years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
69.4 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
69.6 Years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
359 Participants
n=4 Participants
|
|
Antiplatelet Drug or Anticoagulant Drug
Yes
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Antiplatelet Drug or Anticoagulant Drug
No
|
126 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
372 Participants
n=4 Participants
|
|
Daily Dose of Low-Dose Aspirin
81 mg
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Daily Dose of Low-Dose Aspirin
100 mg
|
144 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
429 Participants
n=4 Participants
|
|
Diagnostic Test of H.pylori. (IgG Antibody)
Positive
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Diagnostic Test of H.pylori. (IgG Antibody)
Negative
|
84 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
255 Participants
n=4 Participants
|
|
Primary Disease
Angina Pectoris (Yes)
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Primary Disease
Angina Pectoris (No)
|
88 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Primary Disease
Myocardial Infarction (Yes)
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Primary Disease
Myocardial Infarction (No)
|
129 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
380 Participants
n=4 Participants
|
|
Primary Disease
Ischemic Cerebrovascular Disease (Yes)
|
79 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
234 Participants
n=4 Participants
|
|
Primary Disease
Ischemic Cerebrovascular Disease (No)
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Primary Disease
Coronary Arterial Bypass Grafting or PTCA (Yes)
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Primary Disease
Coronary Arterial Bypass Grafting or PTCA (No)
|
104 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
|
Primary Disease
Other (Yes)
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Primary Disease
Other (No)
|
150 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
446 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
Outcome measures
| Measure |
Rabeprazole 5 mg
n=150 Participants
Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Rabeprazole 10 mg
n=151 Participants
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Teprenone 150 mg
n=151 Participants
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
|
|---|---|---|---|
|
Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
|
2.8 Events/100 participants/24 weeks
Interval 1.04 to 7.17
|
1.4 Events/100 participants/24 weeks
Interval 0.35 to 5.51
|
21.7 Events/100 participants/24 weeks
Interval 15.84 to 29.27
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.
Outcome measures
| Measure |
Rabeprazole 5 mg
n=150 Participants
Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Rabeprazole 10 mg
n=151 Participants
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Teprenone 150 mg
n=151 Participants
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
|
|---|---|---|---|
|
Cumulative Incidence of Bleeding Ulcers
|
0 Events/100 participants/24 weeks
Interval 0.0 to 0.0
|
0 Events/100 participants/24 weeks
Interval 0.0 to 0.0
|
4.6 Events/100 participants/24 weeks
Interval 2.24 to 9.48
|
Adverse Events
Rabeprazole 5 mg
Serious events: 10 serious events
Other events: 48 other events
Deaths: 0 deaths
Rabeprazole 10 mg
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
Teprenone 150 mg
Serious events: 10 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabeprazole 5 mg
n=156 participants at risk
Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Rabeprazole 10 mg
n=157 participants at risk
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Teprenone 150 mg
n=158 participants at risk
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
1.3%
2/158 • 24 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.64%
1/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
0.00%
0/158 • 24 weeks
|
Other adverse events
| Measure |
Rabeprazole 5 mg
n=156 participants at risk
Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Rabeprazole 10 mg
n=157 participants at risk
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
|
Teprenone 150 mg
n=158 participants at risk
Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/156 • 24 weeks
|
3.2%
5/157 • 24 weeks
|
3.8%
6/158 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
4/156 • 24 weeks
|
3.8%
6/157 • 24 weeks
|
1.3%
2/158 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
25/156 • 24 weeks
|
14.0%
22/157 • 24 weeks
|
15.8%
25/158 • 24 weeks
|
|
Infections and infestations
Pharyngitis
|
3.8%
6/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
1.3%
2/158 • 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
5/156 • 24 weeks
|
1.9%
3/157 • 24 weeks
|
1.3%
2/158 • 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
4/156 • 24 weeks
|
0.00%
0/157 • 24 weeks
|
1.9%
3/158 • 24 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.6%
4/156 • 24 weeks
|
1.3%
2/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/156 • 24 weeks
|
0.64%
1/157 • 24 weeks
|
2.5%
4/158 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.64%
1/156 • 24 weeks
|
3.8%
6/157 • 24 weeks
|
0.63%
1/158 • 24 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/156 • 24 weeks
|
3.2%
5/157 • 24 weeks
|
1.9%
3/158 • 24 weeks
|
Additional Information
Nobuyuki Sugisaki
Eisai Co., Ltd.
Phone: +81-3-3817-3908
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER